Virtual Reality-based Therapy and Barriers in Cardiac Patients

July 19, 2023 updated by: Mayara Moura Alves da Cruz, Universidade Estadual Paulista Júlio de Mesquita Filho

Cardiovascular Rehabilitation: Insertion of Virtual Reality-based Therapy and Evaluation of Barriers

The aim of this study is to investigate the chronic hemodynamic and autonomic repercussions of the insertion of VRBT in CR. To qualitatively analyze the perception of patients and physiotherapists regarding the use of VRBT, as well as their association with CR, and through a new questionnaire that takes into account patients 'adherence, identifying which are the main barriers that influence patients' absences.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction: Despite the benefits that cardiovascular rehabilitation programs (CR) can promote, there are problems regarding adherence, which can be related to several factors, among them, motivation. Alternative therapies can reflect on motivation and promote increased adherence to CR. In this context, virtual reality-based therapy (VRBT) appears as an option. Additionally, chronic hemodynamic and autonomic repercussions of VRBT in relation to CV still need to be investigated. Objective: To evaluate the chronic hemodynamic and autonomic repercussions of the insertion of VRBT in CR. To qualitatively analyze the perception of patients and physiotherapists regarding the use of TRV, as well as their association with CR, and through a new questionnaire that takes into account patients 'adherence, identifying which are the main barriers that influence patients' absences. Methods: cardiac patients or individuals with factors that regularly participate in CR will participate in this study. Patients will be randomly allocated to CR + VRBT intervention or keeping the normal routine. Interventions will be carried out three times a week for 12 weeks. The primary outcome will be to assess chronic hemodynamic repercussions (blood pressure, heart rate, respiratory rate, oxygen saturation and perceived exertion using the Borg scale) and autonomic (linear and non-linear data). The secondary outcome consists of a qualitative assessment through a focus group with patients and a focus group with therapists, in addition, the new questionnaire developed to identify the influence of barriers on patients' adherence to CR will be applied.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Presidente Prudente, São Paulo, Brazil, 19060-900
        • Universidade Estadual Paulista Julio de Mesquita Filho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of cardiovascular disease.
  • Clinical diagnosis of cardiovascular risk factors.

Exclusion Criteria:

  • Presence exacerbated signs or symptoms.
  • Balance problems.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evaluation of chronic hemodynamic and autonomic repercussions
Participants in a cardiovascular rehabilitation program will be randomly allocated to CR + VRBT interventions. This group will hold 3 weekly sessions (one for VRBT and two for CR) for 12 weeks. In the first, sixth and last week, chronic hemodynamic data and autonomic data will be evaluated.Furthermore,at the end of 12 weeks, a focus group with therapists and a focus group with patients will be held to identify qualitative aspects in relation to the insertion of VRBT. And in all eligible patients of CR wiil be applied the Questionnaire of barriers identification in frequenters of Cardiovascular Rehabilitation.
Other: virtual reality-based therapy (VRBT)
The warm-up was performed using the "Just Dance 2015" game, in a sequence previously defined in a pilot study, aiming to increase HR progressively. A multimedia projector (Epson Power Life, H309A, China) connected to a console (Xbox One KinectTM, Microsoft, Redmond, WA) was used to project the game onto a white wall.The conditioning phase was performed using the "Shape Up" exercise game, in which patients perform exercises following a virtual therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic autonomic response: linear indices
Time Frame: Change from baseline at 6 and 12 weeks
Measured using heart rate variability : SDNN: the standard deviation of normal-to-normal intervals, ms; rMSSD: the root mean square of successive difference between normal intervals,ms; RRtri: triangular index, based on RR intervals,ms; TINN: triangular interpolation of the normal to normal interval between consecutive heart beats, ms; LF: low frequency, nu; HF: high frequency. In general higher values represent a better autonomic response.
Change from baseline at 6 and 12 weeks
Chronic autonomic response:no linear indices
Time Frame: Change from baseline at 6 and 12 weeks
Measured using heart rate variability : Detrended Fluctuation Analysis, Recurrence Plot, Multiscalar Entropy, symbolic analysis.In general higher values represent a better autonomic response.
Change from baseline at 6 and 12 weeks
Blood pressure
Time Frame: Change from baseline at 6 and 12 weeks
Measured using both systolic blood pressure and diastolic blood pressure
Change from baseline at 6 and 12 weeks
Heart rate
Time Frame: Change from baseline at 6 and 12 weeks
Measured using an equipment validated for recording heart rate beat to beat
Change from baseline at 6 and 12 weeks
Respiratory rate
Time Frame: Change from baseline at 6 and 12 weeks
Measured using the number of respiratory incursions in one minute
Change from baseline at 6 and 12 weeks
Oxygen Saturation
Time Frame: Change from baseline at 6 and 12 weeks
Measured using an oximeter
Change from baseline at 6 and 12 weeks
Perceived Exertion
Time Frame: Change from baseline at 6 and 12 weeks
Measured using Borg Scale, this scale varies from 6 to 20
Change from baseline at 6 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perception of physiotherapists about the barriers and facilitators of the use of Virtual reality
Time Frame: After 12 weeks
Measured by a focal groups with 5 therapist, that used virtual reality. Focal groups will be conducted by a researcher using a previously developed script, with open questions. The moderator will be a PhD student, with previous experience in physical training and qualitative research. A second researcher will be present at the focal groups to detail notes of the participant's answers.
After 12 weeks
Perception of patients about Virtual reality
Time Frame: After 12 weeks
Measured by a 3 focal groups with 4 to 8 patients each, that performed virtual reality. Focal groups will be conducted by a researcher using a previously developed script, with open questions. The moderator will be a PhD student, with previous experience in physical training and qualitative research. A second researcher will be present at the focal groups to detail notes of the participant's answers.
After 12 weeks
Barriers identification in frequenters of Cardiovascular Rehabilitation.
Time Frame: After 12 week
Measured by a new questionnaire of barriers. This new questionnaire has 15 questions, which are divided into domains.
After 12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Investigators

  • Principal Investigator: Mayara MA da Cruz, Master, Universidade Estadual Paulista Julio de Mesquita Filho

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

October 23, 2022

Study Registration Dates

First Submitted

March 31, 2020

First Submitted That Met QC Criteria

April 6, 2020

First Posted (Actual)

April 7, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29742920.9.0000.5402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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